Important Information
INFORMED CONSENT DOCUMENT AGREEMENT TO BE IN A RESEARCH STUDY
| Study Title | Porn Abstinence Impact: Nighttime Erection Trial |
|---|---|
| Study Author | Christos Konstantinidis, Jordan Tsanev |
| Sponsor | This study is made possible by your payment to join. |
| Cost of Products, Services & Information to Participant | $249. (Or free if you already have an Adam Sensor Device) |
| Included Products & Services | Adam Sensor – Nocturnal Erection Tracker |
| Outcome Measures | International Index of Erectile Function Survey; Adam Sensor Nocturnal Penile Tumescence measurements; Aging Male Symptoms Scale (AMS); Daily Men’s Health Check-In; Weekly Porn Consumption Survey; Perceived Stress Scale (Past Week Version) |
| Contact | help@efforia.com |
👍 The table above provides a summary. You may sign now and continue, or read more detail below.
Introduction & Summary
Welcome to this research study on the Efforia platform. This study is made possible by your support through participation and financial contribution. The purpose of this consent form is to help you decide whether taking part is right for you. It explains why the study is being done, what you will do, the possible risks and benefits, how your information may be used, and your rights as a participant.
This study is designed for adult participants who want to better understand whether a 30-day period of pornography abstinence is associated with changes in nighttime erections, sexual function, stress, and related aspects of well-being. This is a structured self-experimentation study in which participants act as their own control over time. Some people may find this experience useful and informative. Others may decide the sensitive topic, the cost, or the possible emotional discomfort make participation a poor fit.
Your participation is voluntary. You may leave the study at any time without penalty. Before deciding whether to join, you should ask any questions you still have and seek answers that are satisfactory to you.
Efforia is a citizen science platform where studies are effectively sponsored by, you, the participants. Unlike traditional research studies, you pay for all the supplies, services, information, and tools needed for participation in one transaction. This makes studies possible that might not be otherwise.
Although you could buy these products and services separately for a similar cost, Efforia bundles them into one purchase for convenience. Efforia organizes these items and provides instructions to create a comprehensive, data-driven research experience. This setup allows you to track and understand the impact on your own life via detailed outcome reports, making informed personal health decisions easier. It also advances broader research findings, benefiting others who might not afford such purchases without guaranteed results.
Efforia is committed to equitable inclusion. If the cost is too high for you, click the large Efforia logo at the top of the screen to explore other protocols. Efforia offers protocols on various topics at different price points, including free options, so you can find one that suits your goals and budget.
Purpose of the Study
The purpose of this study is to evaluate whether 30 days of pornography abstinence is associated with changes in nighttime erections and related measures of male sexual health and well-being. The study is also intended to contribute to broader knowledge about a topic that is widely discussed but not fully understood. In addition to helping generate group-level findings, the study is designed to provide you with structured personal information about your own experience.
The main product used in this study is the Adam Sensor – Nocturnal Erection Tracker. This is a connected health device intended to measure nocturnal penile tumescence, which means erections that occur during sleep. Nighttime erections can reflect aspects of sexual, hormonal, neurologic, and circulatory function. The Adam Sensor is used to collect repeated data during the study.
The study also uses several questionnaires and check-ins. The International Index of Erectile Function Survey is a questionnaire about erectile function and related sexual health. The Aging Male Symptoms Scale (AMS) is a questionnaire about symptoms often discussed in men’s health. The Perceived Stress Scale (Past Week Version) is a questionnaire about stress. The Weekly Porn Consumption Survey and Daily Men’s Health Check-In are used to record your experience during the study, including pornography use, mood, energy, and related observations.
This study is a single-arm longitudinal study where participants act as their own control. That means your baseline data are compared with your later data over time instead of comparing you to a separate group.
What You Will Do as Part of this Study
While participating in this research study, you will need to:
- Be willing and able to follow the study directions and procedures
- Tell Efforia about any side effects or problems by communicating with help@efforia.com or online chat.
- Ask questions as you think of them, via help@efforia.com or online chat.
- Inform Efforia if you change your mind about staying in the study. You may leave the study at any time by communicating with help@efforia.com or chat.
After you complete enrollment, payment, and entry of your personal details, shipping details, and communication preferences, the study will involve the following:
- You will receive the Adam Sensor – Nocturnal Erection Tracker.
- You will complete introductory tasks, including questions about your goals, expectations, and background.
- During the first week, you will continue your normal pornography habits so a baseline can be established.
- During the second week, you will use your Adam Sensor to collect baseline nocturnal erection data.
- You will complete baseline questionnaires, including the International Index of Erectile Function Survey, Aging Male Symptoms Scale, Perceived Stress Scale, and other baseline tasks.
- You will begin a 30-day pornography abstinence commitment and attempt to avoid pornography during that period. If you have a slip, you should report it honestly as study data.
- You will complete follow-up tasks and reminders during the abstinence phase, including repeated questionnaires and ongoing use of the Adam Sensor as directed.
- You may receive notifications by e-mail, SMS, push notification, or within the platform when study tasks are available.
The full study experience lasts about 42 days.
The Risks, Discomforts & Benefits of Being in this Study
There are some unique risks, discomforts, and potential benefits of being in this study that you should understand before joining.
Possible Serious Adverse Events & Side Effects
| Risk name | Risk likelihood | Summary |
|---|---|---|
| Emotional distress | Medium | This study involves sensitive questions about pornography and sexual health that may cause embarrassment, guilt, frustration, shame, or stress. |
| Worsening mental health symptoms in susceptible individuals | Low | For some people, especially those with current or past mental health concerns, the abstinence effort or study focus may worsen anxiety, depression, compulsive thoughts, or emotional instability. |
| Relationship strain | Low | Changes in pornography use or discussions triggered by the study may create tension or conflict in intimate relationships. |
| Sleep discomfort or device discomfort | Low | Using the Adam Sensor while sleeping may be uncomfortable for some participants and may disturb sleep or cause minor physical discomfort. |
| Privacy or confidentiality breach | Low | The study involves sensitive sexual health information, and although protections are used, there is always some risk that private information could be seen or disclosed inappropriately. |
| Unknown risks | Unknown | It is possible that some risks are not known at this time, especially because research on pornography abstinence and personal connected sexual-health devices is still evolving. |
Some People May be at Increased Risk
Some people may be at increased risk from this study and should not join the study before speaking with a medical or other professional with intimate knowledge of your specific circumstances. Without such approval, Efforia strongly encourages you not to join the study or use the associated product and services outside the study.
| Who may be at increased risk | Why they should not join the study without individualized professional guidance |
|---|---|
| Individuals with a history of sexual dysfunction | Participation may worsen symptoms, create stress, or interfere with ongoing treatment or interpretation of symptoms. |
| Individuals with current or past mental health disorders | The abstinence period, sexual-health focus, or self-monitoring process may worsen anxiety, depression, compulsive thoughts, or emotional instability. |
| Individuals with addictive behaviors, including problematic pornography use | Abstinence attempts and repeated monitoring may trigger distress, withdrawal-like feelings, relapse cycles, or psychological discomfort. |
| Individuals with major privacy concerns about sexual-health data | This study involves sensitive personal information that some people may find too private or distressing to track. |
| Individuals whose cultural or religious beliefs strongly conflict with the study topic | Participation may create significant emotional discomfort, conflict, or distress. |
| People below the age of consent or who cannot independently consent | This study is intended for adults who can independently understand the study and give informed consent. |
Consider your Own Risk-Benefit Comfort Level
You should carefully weigh the possible risks, burdens, costs, and benefits of joining this study. In this participant-funded study model, more responsibility is placed on you to decide whether this study is appropriate for your own situation than might be the case in a traditionally sponsored trial.
It is possible that not all risks and benefits are currently known. Participants have the responsibility to consult with their healthcare providers and conduct further research before enrolling in the study.
Privacy & Security Risks
We are doing everything we can think of to keep your data private and confidential. However, there is no such thing as no risk. Potential participants should review the Efforia general privacy policy here: https://efforia.com/privacy-policy/.
There are limits to privacy. Efforia may reach out to local help if we have reason to believe you may be a harm to yourself and/or others. Regulators, such as the FDA or similar agencies, Institutional Review Boards, and other oversight bodies may review study records that include identifying information when needed to review, monitor, or audit research.
The Possible Benefits of Participating Personal and Overall Findings
Efforia will provide you with both personal outcomes and overall findings. These findings may be made available at various data collection points in your experience in the study or as they are discovered by Efforia. These results and findings may affect your interest in continuing in the study. Participation remains voluntary, and you may exit at any time by e-mailing help@efforia.com.
Potential benefits may include better understanding of your own nocturnal erection patterns, pornography use patterns, erectile function, stress, and related well-being measures. Your participation may also contribute to broader knowledge on a topic that remains actively debated and not fully understood.
There is also a possibility that there will be no measurable benefit to you, other than seeing reports that the intervention or treatment had no measurable impact.
What to do if you have a study related injury
If you believe you have a study related injury, side effect, or other problem, you should seek local medical care first, if necessary. Efforia cannot provide emergency medical care or diagnosis. After you have received any necessary local care, it is very important that you contact Efforia at help@efforia.com or through chat to report what happened so we can better understand potential risks and help protect other participants.
Study related injury care and compensation
Efforia will not offer financial compensation nor absorb the costs of medical treatment should you be injured as a result of participating in this research. Efforia makes no commitment to provide free medical care or payment for any study related injury as a result of participation in this study.
In the case of medical emergency
In the case of medical emergency please dial 911 immediately. Do not attempt to contact Efforia until after the emergency has passed. Access local in person medical assistance immediately.
If at any time you feel like you may be a danger to yourself or others, please dial 988 for the National Suicide Prevention hotline. Help is available.
Alternatives to Participating in the Study
Because this study is for research only, the main alternative is not to be in the study. You may choose not to participate. If this study does not seem right for your specific goals, comfort level, or budget, Efforia is dedicated to making other studies available. You may click on the Efforia logo in the upper portion of the page and find a different study that may be more appropriate.
Your Rights as a Participant
Ethical Considerations: Efforia upholds the same high ethical standards in research as seen in pharmaceutical and academic studies, despite only hosting and not sponsoring or conducting these studies. Your participation in this study is completely voluntary, and you are free to withdraw at any time without any adverse consequences. You are not giving up any rights by signing this document.
Your participation in this research study is voluntary. Refusing to participate will not alter your usual health care or involve any penalty or loss of benefits to which you are entitled. If you decide to join the study, you may withdraw at any time and for any reason without penalty or loss of benefits.
Privacy and Confidentiality
You have a right to privacy and confidentiality in this research effort. Your personal information is protected through measures designed to support confidentiality and to reduce unauthorized access and misuse.
The researchers will only use and share information that is needed for the study. The researchers will protect your information, as required by law. Absolute confidentiality cannot be guaranteed because persons outside the study team may need to look at your study records. The Efforia Institutional Review Board may review your study records, and other agencies, committees, and offices that review and monitor research studies may also review them. The purpose for using and sharing your information is to make sure the study is done properly.
By signing this consent form, you are giving permission for Efforia to use and share your health information. If you decide not to sign the form, you cannot be in the study.
Right to Your Own Results
Participants have the right to a complete explanation of the research once their involvement concludes, particularly if the study involves any form of deception like placebos or controls. Efforia also aims to make personal results and broader study findings available as appropriate over time.
The Right to Leave a Study without Penalty at Any time
If you decide to withdraw from the study, you can do so at any time by visiting your Profile page, selecting “Your Protocols,” and clicking “Leave.” Upon leaving, you will be refunded for any consumable products that have not yet been shipped. For non-consumable products, a full refund will be issued upon their return in accordance with our return policy. This ensures that you can participate in the study with the assurance that your financial contributions are handled fairly and with respect for your consumer rights.
If information generated from this study is published or presented, your identity will not be revealed. In the event new information becomes available that may affect the risk or benefit associated with this study or your willingness to participate in it, you will be notified so that you can decide whether or not to continue participating.
Conflict of Interest Statement
As part of our commitment to ethical conduct and transparency in this citizen science clinical trial, it is essential to disclose the unique structure of this study. This clinical trial is hosted by Efforia, but it is uniquely sponsored by you, the participants. Efforia serves solely as the platform provider and does not sponsor or influence the study outcomes.
How Efforia makes money on this protocol: Efforia takes a transaction fee on all the products and services included in this protocol. Otherwise, Efforia has no financial interest in your results and no additional conflict of interest in whether this study shows benefit, no benefit, or mixed findings. To further reduce conflicts of interest, Efforia will remind you once if you do not complete enrollment in this study. Efforia will not remarket to you, nor otherwise push you to join the study.
How we Reduce Conflicts of Interest
You also have a role in reducing conflicts of interest. It is crucial that participants do not have any financial relationship with the intervention methods or measurement providers used in the trial, and are not employees, investors, stakeholders, or protocol authors associated with these entities. Participation under such conflicts of interest could significantly compromise the study’s integrity and the validity of its results.
Consequences of Conflict of Interest Non-Compliance
Should you fail to disclose such a conflict of interest, or if a breach of this policy is discovered, you will be subject to immediate suspension from this platform and payments may not be refunded.
By joining this trial, you affirm that you understand the above conflict of interest restrictions and agree to comply fully with them. Your participation is valued, and your adherence to these guidelines ensures the validity and reliability of our collective scientific efforts.
Data Protections
Data from this study may include information you provide directly, data generated through questionnaires and check-ins, device-generated data from the Adam Sensor, account information, communications preferences, and operational data needed to run the study. Efforia uses this information to operate the study, provide your individual results, analyze pooled findings across participants, improve study operations, and meet legal, safety, ethical, and regulatory obligations. Data protections are designed to comply with applicable data protection laws and research oversight expectations.
What you can do to improve your privacy and security
As part of participating in this study, you will receive notifications via e-mail, SMS, or push notification when new study tasks like questionnaires and reminders are ready for you. You can adjust your communication preferences in the Efforia application at any time. If you do not want to receive notifications from this study, do not press the Accept button. You can decide not to join this study, and will not receive notifications. To ensure others do not see these alerts, you should make sure your phone or desktop computer and your e-mail accounts are protected by a password, pin, or other form of access control. You should also avoid sharing your accounts with others or sharing your account passwords. As this study is hosted in Efforia, it is governed by a set of privacy and confidentiality standards that put you, as a participant, in control. You can learn more about your privacy and security rights on Efforia here: https://efforia.com/privacy-policy/.
Who will have access to your data?
Efforia will have access to your data. There may also be partners who have access to some of your data as needed to operate the study, such as device companies, laboratories, technology vendors, connected health platforms, shipping partners, and service providers involved in study operations.
What will we do with your data
We will use the data to show you your own personal results and to pool your results with those of other participants to provide general outcomes. We will not use your information connected with your name or anything that directly connects the data with you for public reporting without your permission.
California Experiential Research Subject’s Bill of Rights
If you are a California participant, California law recognizes important rights for people asked to take part in medical experiments. These rights include the right to understand the nature and purpose of the study, the procedures and devices involved, expected discomforts and risks, possible benefits, alternatives, available medical treatment if complications arise, the opportunity to ask questions, the right to withdraw without prejudice, the right to receive a signed and dated copy of the consent form, and the right to make a decision free from force, fraud, deceit, duress, coercion, or undue influence. You may review Efforia’s privacy policy here: https://efforia.com/privacy-policy/.
Questions or Concerns
This study has been reviewed by the Efforia Institutional Review Board (IRB), a group of independent experts who help protect the rights, safety, and well-being of research participants.
If you have questions about your rights as a participant, or would like to speak with someone outside the research team, you can contact the IRB at ethics@efforia.com
ETHICS@EFFORIA.COM
Efforia and Efforia IRB have approved the information in this consent form and have given approval to publish this study. This does not mean Efforia or Efforia IRB have approved your being in the study. You must consider the information in this consent form for yourself and decide if you want to be in this study.
If you have questions, please contact help@efforia.com. It is up to you to do additional research and talk to your physician before joining a study.
Additional questions and closing
Efforia has approved the information in this consent form and have given approval to publish this study. This does not mean Efforia has approved or endorses you being in the study. You must consider the information in this consent form and do additional research based on your own situation for yourself and decide if you want to and are appropriate for this study.
If you have questions, please contact help@efforia.com. It is up to you to do additional research and talk to your physician before joining a study.